RSV Vaccine Receives Positive Opinion for Europeans Aged 50-59 at Risk for RSV

GSK plc today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of GSK’s respiratory syncytial virus (RSV) vaccine Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by RSV from adults aged 60 and above to include adults aged 50-59 years at increased risk for RSV disease.    

GSK said in a press release on July 29, 2024, that today’s positive opinion is the first time that CHMP has recommended an indication for adults aged 50-59 for an RSV vaccine. The European Commission’s final decision is expected by September 2024. 

The U.S. FDA approved Arexvy for adults aged 50-59 at increased risk of RSV in June 2024.

Since June 2023, Arexvy has been approved in Europe for adults aged 60 and over to prevent RSV-LRTD. 

GSK has also filed regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other geographies, with regulatory decisions undergoing review.

Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk due to certain underlying medical conditions and in immunocompromised adults aged 18 and over are expected to read out in H2 2024.   

Adults with underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, heart failure, and diabetes, are at increased risk for severe consequences from an RSV infection. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.

In the United States, three approved RSV vaccines are available in July 2024.